Biostrip Sterile Wound Closure Strip

FDA 510(k) K946321 · Cornelia Damsky, Inc.

Substantially Equivalent

510(k) numberK946321

Submission

Device name
Biostrip Sterile Wound Closure Strip
Applicant
Cornelia Damsky, Inc.
Stamford, CT, US
Received
December 28, 1994
Decision date
January 12, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FPX – Strip, Adhesive, Closure, Skin
Device class
Class I (low risk)
Regulation
21 CFR 880.5240
Specialty
General Hospital

Other 510(k)s with product code FPX

510(k)DeviceApplicantDecision
K970441K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional Medi-Flex Hospital Products, Inc.05/09/1997SE
K952947Delpore Skin ClosureFPX · Traditional Bitco Intl.07/24/1995SE
K952702Derma SealFPX · Traditional Ttl Medical06/28/1995SE
K931005Dukal Skin Closure StripFPX · Traditional Dukal Corp.07/14/1993SE
K921775Spyroflex Wound ClosuresFPX · Traditional Polymint Industrial Co. , Ltd.05/19/1992SE
K894802Awc Butterfly Wound ClosuresFPX · Traditional American White Cross, Inc.01/31/1990SE
K894205Tecnol Silk StripFPX · Traditional Tecnol New Jersey Wound Care, Inc.07/25/1989SE
K874813Omed Wound Closure StripsFPX · Traditional Oxboro Medical Intl., Inc.01/29/1988SE
K840945Skin ClosureFPX · Traditional Gainor Medical10/31/1984SE
K842621Suture StripFPX · Traditional Genetic Laboratories, Inc.10/25/1984SE

More from Genetic Laboratories, Inc.

510(k)DeviceDecision
K001322Performer 30 HPSGEX · Traditional 06/30/2000SE
K852858Stretch Bandage · Traditional 07/26/1985SE
K8528574 X 4' Gauze PadEFQ · Traditional 07/26/1985SE

Questions and answers

When was Biostrip Sterile Wound Closure Strip cleared by the FDA?

Biostrip Sterile Wound Closure Strip (K946321) received a 510(k) decision of Substantially Equivalent on January 12, 1995, 15 days after the submission was received.

What is the product code of K946321?

The FDA product code is FPX – Strip, Adhesive, Closure, Skin, a Class I (low risk) device regulated under 21 CFR 880.5240.